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This is a study to evaluate the impact of returning research results that indicate a five-year risk estimate of Alzheimer disease dementia to participants without memory or thinking problems of the Knight Alzheimer Disease Research Center at Washington University in St. Louis.
All participants without memory or thinking problems in a longitudinal observational cohort of aging (Memory and Aging Project) will be offered a five-year Alzheimer dementia risk estimate report that incorporates genetic and either neuroimaging research results or plasma amyloid results as well as demographic information into five-year Alzheimer disease dementia risk estimate. Using a two-year delayed-start randomized clinical trial design, participants will be randomized to receive research results either two weeks (Arm A/C) or one year (Arm B/D) after informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Participants randomized to Arm A will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm A is a neuroimaging arm. |
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| Arm B | Active Comparator | Participants randomized to Arm B will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm B is a neuroimaging arm. |
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| Arm C | Active Comparator | Participants randomized to Arm C will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm C is a plasma amyloid arm. |
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| Arm D | Active Comparator | Participants randomized to Arm D will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm D is a plasma amyloid arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A , Arm B, Arm C, & Arm D | Other | All arms will receive the same intervention, but at different time points. All arms will be offered the option to learn their research results in personalized five-year risk estimate of getting Alzheimer disease dementia. Arms A & C participants will receive their risk estimate about two weeks after consent is signed and Arms B& D will receive their risk estimate about one year after consent is signed. The risk estimate returned to participants is based on research results from individual genotyping results, imaging or plasma amyloid testing & demographic characteristics. All arms will complete psychosocial and cognitive testing. Also, surveys used in this study will ask about participants' experiences and feelings after learning their risk estimate. All arms will receive follow up calls at one week post disclosure of the risk estimate and surveys two, six, and twelve months post disclosure. Arms A & C will have extra surveys at twenty-four months post disclosure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Geriatric Depression Scale (GDS) | GDS is a questionnaire that screens for depression in older adults. It's a self-report tool that asks yes or no questions about how a person has been feeling over the past week. | Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial. GDS is also measured at the time of informed consent. |
| Change in Clinical Dementia Rating sum of box score (CDR-SB) | Subjective measure of dementia determined as part of clinical assessment. | Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial. |
| Change in cognitive composite score | Objective measure of cognitive functioning. | Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Events Scale Revised (IES-R) | A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. | 2, 6, 12 and 24 months post-disclosure of risk estimate. |
| Decision Regret Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Hartz, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42326827 | Derived | Hartz SM, Jackson S, Benzinger TLS, Bierut L, Evans A, Goswami S, Gordon BA, Hassenstaab J, Hayibor L, Linnenbringer E, Morris JC, Moulder KL, Oliver A, Sun L, Schindler SE, Xiong C, Mozersky J. No cognitive or psychological impact from returning research Alzheimer disease biomarkers: A delayed-start, noninferiority, randomized clinical trial. medRxiv [Preprint]. 2026 Jun 10:2026.05.22.26353881. doi: 10.64898/2026.05.22.26353881. | |
| 41500647 |
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Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.
Data will be available immediately following publication with no end date.
Access Criteria: Qualified researchers who provide a methodologically sound proposal will be able to access the data to achieve aims in the approved proposal.
Proposals should be directed to hartzs@wustl.edu. To gain access, requestors will need to sign a data access agreement.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 29, 2026 | |
| Unrelease | Jun 12, 2026 | |
| Release | Jun 12, 2026 |
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The Decision Regret Scale measures "distress or remorse" after receiving research results. |
| 2, 6, 12 and 24 months post-disclosure of risk estimate. |
| Self- Report Heath Care Utilization | This scale measures self-reported health care utilization that indicates both patients' health and their ability to self-manage their condition. | At consent, 6, 12 and 24 months post-disclosure of risk estimate |
| Understanding of Research Results | The scale measures participant's comprehension of their research results. | 2, 12 and 24 months post-disclosure of risk estimate. |
| Patient Assessment of Communication Effectiveness | This scale investigates participants' perspectives on communication and to measure how well the research team communicated research results to participants | 2 months post-disclosure of risk estimate. |
| Lifestyle/Health Behavior Change | This scale gauges self-reported preparedness of future health and end of life situations. | 6, 12 and 24 months post-disclosure of risk estimate. |
| AD-Related Distress | This scale measures participants' self-reported anxiety (psychological impact) about developing AD dementia. | At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate. |
| Future Time Perspective | This scale measures how participants' feel about future events and their self-reported agreement or disagreement with the future events. | At consent, 12 and 24 months post-disclosure of risk estimate. |
| Modified Social Impact Scale | This scale assesses whether participant's self-image after learning research results indicating risk of developing AD dementia is affected by notions of stigma. | 2, 6, 12 and 24 months post-disclosure of risk estimate. |
| Views Regarding Research | This scale assesses the impact of learning research results on attitudes towards research participation. | At consent, 6 and 12 months post-disclosure of risk estimate. |
| Derived |
| Hartz SM, Goswami S, Oliver A, Evans A, Jackson S, Linnenbringer E, Moulder KM, Morris JC, Mozersky J. What is the psychological and cognitive impact of returning Alzheimer disease dementia research results to healthy research participants? a delayed-start randomised clinical trial protocol for the WeSHARE study (Washington University study of having Alzheimer disease research results explained). BMJ Open. 2026 Jan 6;16(1):e099970. doi: 10.1136/bmjopen-2025-099970. |
| Reset | Jul 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2026 | Jun 12, 2026 | |||
| Jun 12, 2026 | Jul 9, 2026 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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